Department of Health and Human Services June 10, 2005 – Federal Register Recent Federal Regulation Documents

On February 9, 2005, the Office of Community Services, Administration for Children and Families, U.S. Department of Health and Human Services published an announcement seeking applications for the Assets for Independence Program. The announcement appeared in Volume 70, pages 6879-6888 of the Federal Register. This document announces one additional application due date of July 15, 2005, which is in addition to the three due dates listed in the February 9 standing announcement (March 15, June 15 and November 1). To be considered timely for this additional due date only, applications must be received at the OCS Operations Center by July 15. (For more details, see submission dates and times section below.) This document also announces two informational telephone conference calls concerning the Assets for Independence Program and the process for submitting a grant application. Submission Dates and Times: The new additional closing date for the Assets for Independence Program is July 15, 2005. (This closing date is in addition to three other valid closing datesMarch 15, June 15 and November 1as noted in the current standing announcement.) Applications received after 4:30 p.m. eastern time on the July 15 closing date will be classified as late, and will not be reviewed this cycle. Deadline: Applications shall be considered as meeting an announced deadline if they are received on or before the due date. Applicants are responsible for ensuring applications are mailed or submitted electronically well in advance of the application due date. Applications hand carried by applicants, applicant couriers, other representatives of the applicant, or by overnight/express mail couriers shall be considered as meeting an announced deadline if they are received on or before the deadline date, between the hours of 8 a.m. and 4:30 p.m., eastern time, between Monday and Friday (excluding Federal holidays). ACF cannot accommodate transmission of applications by facsimile. Therefore, applications transmitted to ACF by fax will not be accepted regardless of date or time of submission and time of receipt. Receipt acknowledgement for application packages will not be provided to applicants who submit their package via mail, courier services, or by hand delivery. Applicants will receive an electronic acknowledgement for applications that are submitted via Grants.gov. Late Applications: Applications that do not meet the criteria above are considered late applications. ACF shall notify each late applicant that its application will not be considered in the current competition. Any application received after 4:30 p.m. eastern time on the deadline date will not be considered for competition. Applicants using express/overnight mail services should allow two working days prior to the deadline date for receipt of applications. Applicants are cautioned that express/overnight mail services do not always deliver as agreed. Extension of Deadlines: ACF may extend application deadlines when circumstances such as acts of God (floods, hurricanes, etc.) occur, or when there are widespread disruptions of mail service, or in other rare cases. A determination to extend or waive deadline requirements rests with the Chief Grants Management Officer. Other Submission Requirements: Submission by Mail: An applicant must provide an original application with all attachments, signed by an authorized representative and two copies. The application must be received at the address below by 4:30 p.m. eastern time on or before the closing date. Applications should be mailed to: Administration for Children and Families, Office of Community Services' Operations Center, 1515 Wilson Boulevard, Suite 100, Arlington, VA 22209, Attention: Administration for Children and Families, Office of Community Services, Assets for Independence Program. Hand Delivery: An applicant must provide an original application with all attachments signed by an authorized representative and two copies. The application must be received at the address below by 4:30 p.m. eastern time on or before the closing date. Applications that are hand delivered will be accepted between the hours of 8 a.m. to 4:30 p.m. eastern time, Monday through Friday. Applications should be delivered to: Administration for Children and Families, Office of Community Services' Operations Center, 1515 Wilson Boulevard, Suite 100, Arlington, VA 22209; Attention: Administration for Children and Families, Office of Community Services, Assets for Independence Program. Electronic Submission: https://www.Grants.gov. Please see Section IV.2 Content and Form of Application Submission of the February 9 announcement, for guidelines and requirements when submitting applications electronically. Informational Conference Calls: The Office of Community Services will host two informational telephone conference calls concerning the Assets for Independence Program and the grant application process on June 20 and 21, 2005 at 2 p.m. until approximately 3 p.m. These calls will be open to all interested individuals. Please call the Office of Community Services on (202) 401-4626 or go to the OCS Asset Building Web site at https://www.acf.hhs.gov to register for a call and for dial- in information. Participants are strongly encouraged to register, as the number of lines is limited. OCS plans to make handout materials available to all individuals who register for either of the informational calls. Announcement Availability: The Assets for Independence Program announcement and all application materials are available at https:// www.Grants.gov. Standard forms and certifications may also be found at https://www.acf.hhs.gov/programs/ofs/forms.htm. Finally, the OCS Asset Building Web site at https://www.acf.hhs.gov/assetbuilding provides much information about the Assets for Independence Program and the application process. The page includes links to all required forms as well as to a guidebook for developing an AFI Project and applying for an AFI grant.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including renewal of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting and recordkeeping requirements for distribution and use of Veterinary Feed Directive (VFD) drugs and animal feeds containing VFD drugs.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, limited field of use, exclusive license to practice the inventions embodied in the patent application referred to below to AerovectRx (AVRX), Corporation having a place of business in Norcross, Georgia. The patent rights in these inventions have been assigned to the government of the United States of America. The patent applications to be licensed are:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.